| Popis: |
Objective To test the hypothesis that over a 4-week treatment period, Nal-Glu GnRH antagonist ([AcD2Nal 1 , D4ClPhe 2 , D3Pal 3 , Arg 5 , DGlu 6 [AA], DAla 10 ] GnRH) at a dose of 200 μ g/kg per day SC would suppress levels of immunologically active and biologically active LH and FSH more completely than a dose of 100 μ g/kg per day. Design Placebo controlled clinical study. Setting A university community. Subjects Thirty normal male volunteers. Interventions We administered Nal-Glu at doses of 0, 100, and 200 μ g/kg body weight per day in combination with T enanthate, 50 mg IM weekly, to separate groups of men (9 or 10 men per group) for 4 weeks. Results Serum levels of immunologically active and biologically active gonadotropins were suppressed similarly in both groups of men who received Nal-Glu; this suppression was significantly greater than in the men who received placebo + T. Local side effects were more severe in the Nal-Glu 200 μ g/kg per day group. Conclusions Administration of Nal-Glu in combination with T suppresses gonadotropins more completely than does T alone, but at doses > 100 μ g/kg, gonadotropins are not suppressed additionally with larger doses of Nal-Glu. Subjects experienced greater local discomfort and side effects with the higher dosage. These findings suggest that dosages of Nal-Glu of >100 μ g/kg per day may have no advantage over the 100- μ g/kg dose in a male contraceptive regimen. |
